Status:
RECRUITING
Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (...
Eligibility Criteria
Inclusion
- Informed consent signature
- Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol
- Age \> 18 years
- Cohort 1:
- Diagnosis of non-metastatic breast cancer (M0/Mx according to TNM system) who have undergone surgical and/or chemotherapy and/or immunotherapy and/or radiotherapy and/or endocrine treatment.
- Postmenopausal women (FSH \> 30 UIIU/L, E2 \< 20 pg/ml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with LHRH analog +/- tamoxifen and/or aromatase inhibitor for at least 6 months.
- At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).
- Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).
- Cohort 2:
- Postmenopausal women (FSH \> 30 UI/L, E2 \< 20 pg/ml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago.
- At least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the MBS scale).
- Signs of pelvic static alterations not exceeding POP-Q score 2 (POP-Q).
Exclusion
- Other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present;
- HRT in progress or discontinued for less than 6 months;
- Ongoing vulvo-vaginal and urinary infections;
- Bleeding of ndd;
- Pathological pap-test within the previous 12 months.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06879938
Start Date
October 16 2023
End Date
December 1 2025
Last Update
March 17 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
Pavia, Pavia, Italy, 27100